Test Catalog

Test Id : PFCEA

Carcinoembryonic Antigen (CEA), Pleural Fluid

Useful For
Suggests clinical disorders or settings where the test may be helpful

An adjuvant to cytology and imaging studies to differentiate between nonmalignant and malignant causes of pleural effusions

Method Name
A short description of the method used to perform the test

Immunoenzymatic Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

CEA, Pleural Fluid

Aliases
Lists additional common names for a test, as an aid in searching

CEA (Carcinoembryonic Antigen)

Specimen Type
Describes the specimen type validated for testing

Pleural Fluid

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: Plain, plastic, screw-top tube

Specimen Volume: 2 mL

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Pleural Fluid Frozen (preferred) 90 days
Refrigerated 14 days
Ambient 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

An adjuvant to cytology and imaging studies to differentiate between nonmalignant and malignant causes of pleural effusions

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Pleural effusions occur as a consequence of either nonmalignant conditions (including congestive heart failure, pneumonia, pulmonary embolism, and liver cirrhosis) or malignant conditions (including lung, breast, and lymphoma cancers). Diagnosing the cause of an effusion can be difficult, often requiring cytological examination of the pleural fluid and imaging studies of the pleural tissue. Analysis of various tumor markers in pleural fluid has shown that these markers can differentiate between effusions caused by nonmalignant and malignant conditions and can enhance cytology and imaging findings.

 

Carcinoembryonic antigen (CEA) is a glycoprotein produced during fetal development. Nonsmoking, healthy adults typically produce low to undetectable levels of CEA. Serum concentrations of CEA may be elevated in patients with certain malignancies that secrete CEA into circulation, including medullary thyroid carcinoma and breast, gastrointestinal tract, colorectal, liver, lung, ovarian, pancreatic, and prostate cancers.

 

Pleural fluid concentrations of CEA have been reported to be elevated in patients with certain malignancies. Malignancies that can secrete CEA and elevate serum CEA concentrations, including lung, breast, ovarian, gastrointestinal, and colorectal cancers, typically also elevate CEA in pleural fluid. In contrast, malignancies that do not secrete CEA, including mesothelioma, lymphoma, leukemia, and melanoma, have low concentrations of CEA in pleural fluid comparable to concentrations observed in non-malignant effusions.

 

Elevated CEA concentrations in pleural fluid have also been reported with certain nonmalignant conditions, including liver cirrhosis, pancreatitis, complicated parapneumonic effusions and empyemas, and rarely with tuberculosis.

 

CEA results should be used in conjunction with cytological analysis of pleural fluid, imaging studies, and other clinical findings.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

A pleural fluid carcinoembryonic antigen (CEA) concentration of 3.5 ng/mL or higher is suspicious but not diagnostic of a malignant source of the effusion. This cutoff yielded a sensitivity of 52%, specificity of 95%, and part per volume of 93% in a study of 200 patients presenting with effusion. CEA concentrations were significantly higher in effusions caused by CEA-secreting malignancies, including lung, breast, ovarian, gastrointestinal, and colorectal cancers. However, effusions caused by non-CEA-secreting malignancies, including lymphoma, mesothelioma, leukemia, and melanoma, routinely had CEA concentrations below 3.5 ng/mL. Therefore, negative results should be interpreted with caution, especially in patients who have or are suspected of having a non-CEA-secreting malignancy.

 

Correlation of all tumor marker results with cytology and imaging is highly recommended.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test result should not be the sole basis for diagnosis. Carcinoembryonic antigen (CEA) and other tumor markers are not specific for malignancy and CEA testing has limited utility when used as the sole diagnostic test. Test results should be always correlated with cytology, imaging, and other clinical findings.

 

A low or negative CEA result may be misleading, as certain malignancies do not secrete CEA and will not produce elevated CEA concentrations in pleural effusions. Negative results should be interpreted with caution in patients who have or are suspected of having a non-CEA-secreting malignancy or who have a cancer of unknown primary origin. Alternative methodologies, including cytology, imaging, and other tumor markers should be considered.

 

CEA concentrations have been reported to be elevated in pleural fluid as a consequence of certain nonmalignant conditions, including liver cirrhosis, pancreatitis, complicated parapneumonic effusions and empyemas, and rarely with tuberculosis. Results should be interpreted with caution in patients with those conditions.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Shitrit D, Zingerman B, Shitrit ABG, Shlomi D, Kramer MR: Diagnostic value of CYFRA 21-1, CEA, CA 19-9, CA 15-3, and CA 125 assays in pleural effusions: analysis of 116 cases and review of the literature. Oncologist. 2005 Aug;10(7):501-507

2. Hackbarth JS, Murata K, Reilly WM, Algeciras-Schimnich A: Performance of CEA and CA19-9 in identifying pleural effusions caused by specific malignancies. Clin Biochem. 2010 Sep;43(13-14):1051-1055

3. Garcia-Pachon E, Padilla-Navas I, Dosda MD, Miralles-Llopis A: Elevated level of carcinoembryonic antigen in nonmalignant pleural effusions. Chest. 1997 Mar;111(3):643-647

4. Hackner K, Errhalt P, Handzhiev S: Ratio of carcinoembryonic antigen in pleural fluid and serum for the diagnosis of malignant pleural effusion. Ther Adv Med Oncol. 2019 May 22;11:1758835919850341. doi: 10.1177/1758835919850341

5. Tozzoli R, Basso SM, D'Aurizio F, Metus P, Lumachi F: Evaluation of predictive value of pleural CEA in patients with pleural effusions and histological findings: A prospective study and literature review. Clin Biochem. 2016 Nov;49(16-17):1227-1231. doi: 10.1016/j.clinbiochem.2016.08.006

Method Description
Describes how the test is performed and provides a method-specific reference

The instrument used is Beckman Coulter UniCel DXI 800. The Access CEA assay is a 2-site immunoenzymatic sandwich assay using mouse monoclonal carcinoembryonic antigen (CEA) antibodies that react with different epitopes of CEA. A sample is added to a reaction vessel, along with the first CEA monoclonal antibody-alkaline phosphatase conjugate and the second CEA monoclonal antibody bound to paramagnetic particles. The incubation is followed by a magnetic separation and washing. A chemiluminescent substrate is added to the vessel, and the light generated by the reaction is measured with a luminometer. The light production is proportional to the concentration of CEA in the sample. The amount of analyte in the sample is determined by means of a stored, multipoint calibrator curve.(Package insert: Access CEA Assay, Beckman Coulter, Inc; 2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

12 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

82378

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
PFCEA CEA, Pleural Fluid 19169-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
PCEA CEA, Pleural Fluid 19169-2
SITE9 Site 39111-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports